Pharmacovigilance in Gerontopsychiatric Patients

Overview

The purpose of this multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment.

The aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises.

To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites.

At Baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ECG will be assessed.

Afterwards patients are visited weekly and screened for possible adverse drug reactions. All adverse drug reactions will be coded in the MedDRA-system.

In case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. Drug combinations will be analysed using an established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible adverse drug reactions are documented continually.

2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 28, 2017

Interventions

  • Drug: Phenobarbital
  • Drug: Phenytoin
  • Drug: Carbamazepine
  • Drug: Oxcarbazepine
  • Drug: Valproic Acid
  • Drug: Lamotrigine
  • Drug: Topiramate
  • Drug: Gabapentin
  • Drug: Levetiracetam
  • Drug: Pregabalin
  • Drug: Lacosamide
  • Drug: Clonazepam
  • Drug: Biperiden
  • Drug: Levomepromazine
  • Drug: Fluphenazine
  • Drug: Perphenazine
  • Drug: Perazine
  • Drug: Thioridazine
  • Drug: Haloperidol
  • Drug: Melperone
  • Drug: Pipamperone
  • Drug: Bromperidol
  • Drug: Benperidol
  • Drug: Sertindole
  • Drug: Ziprasidone
  • Drug: Flupentixol
  • Drug: Chlorprothixene
  • Drug: Zuclopenthixol
  • Drug: Fluspirilene
  • Drug: Pimozide
  • Drug: Clozapine
  • Drug: Olanzapine
  • Drug: Quetiapine
  • Drug: Sulpiride
  • Drug: Tiapride
  • Drug: Amisulpride
  • Drug: Prothipendyl
  • Drug: Risperidone
  • Drug: Aripiprazole
  • Drug: Paliperidone
  • Drug: Diazepam
  • Drug: Oxazepam
  • Drug: Lorazepam
  • Drug: Bromazepam
  • Drug: Clobazam
  • Drug: Alprazolam
  • Drug: Hydroxyzine
  • Drug: Buspirone
  • Drug: Chloral Hydrate
  • Drug: Flurazepam
  • Drug: Nitrazepam
  • Drug: Triazolam
  • Drug: Lormetazepam
  • Drug: Temazepam
  • Drug: Midazolam
  • Drug: Brotizolam
  • Drug: Zopiclone
  • Drug: Zolpidem
  • Drug: Zaleplon
  • Drug: Melatonin
  • Drug: Clomethiazole
  • Drug: Diphenhydramine
  • Drug: Promethazine
  • Drug: Imipramine
  • Drug: Clomipramine
  • Drug: Opipramol
  • Drug: Trimipramine
  • Drug: Amitriptyline
  • Drug: Nortriptyline
  • Drug: Doxepin
  • Drug: Maprotiline
  • Drug: Amitriptyline oxide
  • Drug: Fluoxetine
  • Drug: Citalopram
  • Drug: Paroxetine
  • Drug: Sertraline
  • Drug: Fluvoxamine
  • Drug: Escitalopram
  • Drug: Tranylcypromine
  • Drug: Moclobemide
  • Drug: Mianserin
  • Drug: Trazodone
  • Drug: Mirtazapine
  • Drug: Bupropion
  • Drug: Venlafaxine
  • Drug: Reboxetine
  • Drug: Duloxetine
  • Drug: Agomelatine
  • Drug: Pyritinol
  • Drug: Piracetam
  • Drug: Donepezil
  • Drug: Rivastigmine
  • Drug: Galantamine
  • Drug: Memantine
  • Drug: Nicergoline
  • Drug: Acamprosate
  • Drug: Lithium

Arms, Groups and Cohorts

  • Experimental: Psychiatric drugs

Clinical Trial Outcome Measures

Primary Measures

  • Assessment of frequency and severity of adverse events
    • Time Frame: Participants will be followed for the duration of hospital stay and the follow-up-visit, an expected average of 6 weeks

Secondary Measures

  • Assessment of cognitive functioning
    • Time Frame: At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)
    • Mini mental state examination, intensive care delirium checklist
  • Quality of life
    • Time Frame: At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)
    • SF-8
  • Adverse drug reactions
    • Time Frame: Continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge
    • Dosage record and treatment emergent symptoms scale (DOTES), geriatric adverse event rating scale (GEARS)
  • Serum level of substances
    • Time Frame: 1 day at occurrence of SAR
  • Electrocardiogram
    • Time Frame: At baseline visit, at occurrence of SAR and at the final visit (expected average of hospital stay: 4 weeks)
  • Medication intake
    • Time Frame: Patients medication intake 2 weeks before hospitalization, continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge
    • Morisky medication adherence scale (MMAS) and chart review

Participating in This Clinical Trial

Inclusion Criteria

  • Age 65+ years old
  • Inpatients treated at one of the geriatric psychiatry study sites.
  • Signed consent form ( Patient and/or legally authorized custodian)

Exclusion Criteria

  • Patients that are incapable to give their informed consent and are not under legally authorized custodianship.
  • Parallel participation in another clinical trial.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hannover Medical School
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Helge Frieling, Prof., MD, Principal Investigator, Hannover Medical School

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